HIV Infection Clinical Trial
Official title:
Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal
In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment
available for HIV-1 infected patients. The combination proposed is a triple antiretroviral
therapy with only one intake of 3 pills per day. This combination has already been studied
in the North countries.
Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48
and 96 weeks of treatment.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented infection with HIV-1 (ELISA- Western Blot) - Outpatient of masculine or feminine gender - In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device - No previous treatment with antiretroviral therapy - CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml. - Patient has provided informed written consent - Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator Exclusion Criteria: - Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible - Patient participating in a different clinical study - Presence of serious or developing pathology - Severe liver failure (TP under 50% et bilirubinemia over 3 LSN) - Thrombocytopenia with platelet level under 50 000 cells /ml - Known severe renal pathology (creatinine clearance under 50 ml/min) - Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification - Karnofsky under 70 percent - Opportunistic infections - Patients taking medications not recommended in the context of the protocol |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Senegal | Centre de Traitement Ambulatoire, CHU de Fann | Dakar | |
Senegal | Service des Maladies Infectieuses, CHU de Fann | Dakar |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis | Gilead Sciences, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
Senegal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population | S48 | ||
Secondary | Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml | S24 and S96 | ||
Secondary | Viral load evolution | S24 and S48 | ||
Secondary | Genotype resistance profile evaluation failing patients | S24, S48, S96 | ||
Secondary | Immune benefits of the combination | |||
Secondary | Plasma concentrations of FTC, TDF and EFV | S4 | ||
Secondary | Adverse events clinic and lipids | |||
Secondary | Compliance | S48 and S96 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01702974 -
Immune Reconstitution in HIV Disease (IREHIV)
|
Phase 2 |